Actively Recruiting

Phase Not Applicable
Age: 60Years - 86Years
All Genders
Healthy Volunteers
NCT06595511

Effects of Combined 40 Hz Audio-visual Stimulation and Cognitive Games on Alzheimer's Disease

Led by Istanbul Medipol University Hospital · Updated on 2024-09-19

30

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

Sponsors

I

Istanbul Medipol University Hospital

Lead Sponsor

T

The Scientific and Technological Research Council of Turkey

Collaborating Sponsor

AI-Summary

What this Trial Is About

In addition to ongoing drug treatments for Alzheimer Disease (AD), protective approaches that can halt the progression of the disease are of particular importance. This project aims to develop a digital application that can monitor cognitive impairment, using EEG findings proven effective at the clinical level in Alzheimer and various types of dementia, including sensory entrainment and digital cognitive games. To this end, a collaboration between Istanbul Medipol University and Güven Future Health Technologies Inc. will develop a device featuring audio-visual sensory entrainment and digital cognitive games. This device will be made available to Alzheimer patients, and the differences between patients who use the application for three months, patients who do not use the application, and healthy controls will be evaluated through neurological examinations, neuropsychological tests, and EEG recordings indicating cognitive functions by the neurologist, project coordinator, and bursars. Monthly assessments, including EEG recordings, will also continue at home, and an application will be created to evaluate changes in cognitive functions through EEG data. By the end of the project, an application that includes sensory entrainment and digital cognitive games, proven effective at the clinical level using EEG findings for Alzheimer dementia patients, will be developed. Additionally, a health kit capable of temporal monitoring of cognitive function changes through EEG data will have been developed.

CONDITIONS

Official Title

Effects of Combined 40 Hz Audio-visual Stimulation and Cognitive Games on Alzheimer's Disease

Who Can Participate

Age: 60Years - 86Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Alzheimer's disease according to DSM-IV and NINCDS-ADRDA criteria
  • Impaired activities of daily living
  • Clinical Dementia Rating (CDR) score between 1 and 2 and Standardized Mini-Mental State (SMMT) score between 15 and 26
  • Stable use of psychoactive medications, including acetylcholinesterase inhibitors or other cognitive enhancers
  • Age between 60 and 86 years with at least 5 years of education
  • Healthy older adults aged 60 to 86 without neurological abnormalities or cognitive impairment (MMSE above 25)
  • No diagnosis of neurological or psychiatric diseases and not using related medications
Not Eligible

You will not qualify if you...

  • Diagnosis of frontotemporal dementia, vascular dementia, Lewy body dementia, or other dementia types
  • Presence of Parkinsonism, clinical depression, other mental disorders, epilepsy, drug or alcohol addiction, or traumatic brain injury
  • Healthy older adults with any clinical signs of cognitive impairment including mild cognitive impairment, Alzheimer's disease, Parkinson's disease, Lewy body dementia, or frontotemporal dementia
  • Use of medications affecting cognitive functions
  • History of epilepsy, alcohol or drug addiction, or traumatic brain injury

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye), 34810

Actively Recruiting

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Research Team

B

Bahar Güntekin, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Effects of Combined 40 Hz Audio-visual Stimulation and Cognitive Games on Alzheimer's Disease | DecenTrialz